Digital Health Technologies - Therapeutic Applications
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This policy governs coverage determinations for FDA-marketed therapeutic digital health applications intended for treatment of panic disorder, PTSD, and nightmare disorder for BCBSRI members; it applies to Medicare Advantage and Commercial products as specified.
No material clinical or coverage changes in this revision.
Coverage Determinations
Named digital therapeutics coverage determinations
Policy determinations for Freespira and NightWare:
Evidence insufficient to determine effect on health outcomes
Evidence insufficient to determine effect on health outcomes
Single pivotal trial did not meet primary endpoint; evidence insufficient
Evidence insufficient; benefit uncertain
Benefits may vary between groups and contracts. Refer to the member’s specific Benefit Booklet, Evidence of Coverage, or Subscriber Agreement to determine whether Freespira or NightWare are covered, not covered, or considered not medically necessary for that contract.
For Commercial Products, both Freespira and NightWare are listed as not medically necessary because the evidence is insufficient to determine their effects on health outcomes.
Billing and Codes
| A9291 | Prescription digital cognitive and/or behavioral therapy, fda cleared, per course of treatment |
Provider Requirements and Billing Guidance
Prior Authorization
Prior authorization: Not applicable.
Step therapy / Benefit variability
Benefits may vary by contract. There are no specific step therapy requirements listed in this policy; coverage depends on the member's contract-specific benefit design. Providers must verify coverage, limitations, and any applicable step therapy or other utilization management rules in the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement before rendering or billing services.
- Coverage depends on contract-specific benefits
- No step therapy requirements specified in this policy
Verify member benefits
Verify member benefits and contract terms prior to providing services. Benefits, coverage determinations, and applicability of medical necessity or not-covered rules vary by group and contract; providers must confirm the member's applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement.
- Providers must verify member-specific coverage before treatment or billing
Billing denial risk for A9291
The HCPCS code A9291 is listed as not covered / not medically necessary for Medicare Advantage and Commercial Products. Billing for A9291 may be denied; do not bill this code for covered services under these products.
- A9291 — Prescription digital cognitive and/or behavioral therapy, FDA cleared, per course of treatment: Not covered / Not medically necessary
Background and Scope
Digital therapeutic applications, often described as Software as a Medical Device (SaMD), are software intended for medical purposes that operate without being part of a hardware medical device. This policy applies to FDA-marketed therapeutic SaMD that are prescribed by a provider and addresses technologies intended to treat conditions such as panic disorder, post-traumatic stress disorder, and nightmare disorder.
Key Definitions
Setting and Level-of-Care Considerations
Digital Therapeutic Modalities
Digital therapeutic (Freespira, NightWare)
Evidence from single-arm studies with high loss to follow-up; insufficient evidence
Single pivotal trial did not meet primary endpoint; insufficient evidence
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